The training course “Drug-device combination products in EU and US” will explore the EU and US regulatory landscape defining the key differences, similarities and provide an overview of the regulatory pathways and how to successfully navigate between drugs, devices and combination products in each jurisdiction. The course will also provide a detailed overview of impact of the EU medical device regulation on combination products and the life cycle management of combination products.
Enhancing capabilities to develop and launch successful combination products will remain a top priority; with product usability, integrating digital platforms and general management across the total product life cycle becoming critical. However, with a regulatory landscape that is inconsistent between EU and US, remaining compliant, maintaining quality and ensuring safety requires clear, concise and consistent guidance on regulations.
Key points of the training
- Understand how combination products are defined and classified in EU and US
- Learn how borderline products are classified in EU and US
- Understand the regulatory pathways and how to successfully navigate between drugs, devices and combination products in each jurisdiction
- Learn about the EU Medical Device Regulation impact on Combination Products
- Gain a deeper understanding of the roles of EU Competent Authorities and Notified Bodies
09:30– 13:00 COURSE SESSION DAY 1
09:30– 13:00 COURSE SESSION DAY 2
9:30 Introduction & speed networking
9:40 Combination Products in EU
- Definitions in EU
- Combination Product
- Medicinal Product
- Medical Device
- Legal framework
- Medicinal product and medical device legislations
- Revision to EU Medical Device Regulation (MDR)
- Regulatory similarities and differences
- Borderline classification in EU: Medical Device or Medicinal product?
- The importance of classification & its implication
- Decision Making on the Borderline
10:20 EU Market access for Drug Device Combination Products (DDCs)
- Single integral non-reusable DDCs
- Non-integral Combination Products (kit)
- Data requirements
- Labelling requirements
- Guidance documents
11:45 Combination Products in US
- Combination Product Definition
- History and Legal Framework
- Borderline Products
- Types of Combination Product (Definitions)
- Primary Mode of Action and FDA’s Assignment Algorithm
- Jurisdiction and Designation Process for Combination Products
13:00 Closure of day one
9:30 EU market access for Device Drug Combination Products
- EU MDR Classification and applicable rule(s)
- Notified Body’s role and obligations
- What is CE Marking?
- CE certification process at a glance
- Documentation requirements at top level
10:15 EU MDR key changes and its Impact on Drug Device Combination Products
- Impact on combination products regulated as medicinal product
- Article 117 and Notified Body Opinion report (NBOp)
- Notified Body selection and Interaction
- Documentation requirements
- Life Cycle management: New or updated NBOp?
- Team-NB position
- Industry perspective
11:20 US market access for Combination Products
- FDA’s approach to Combination Products
- Submissions and Regulatory Pathways
- Current Good Manufacturing Practice (cGMP) Requirements
- Strategies for Development of Combination Products
12:40 Final Questions session
This Training Course is of particular interest to professionals working in:
- Quality Assurance
- Quality Control
- Regulatory Affairs
- Design and development of Combination Products
- Suppling medical devices to the pharma/biotech industry
The course will be carried out through live lectures. Practical examples will be showcased, providing delegates with real life examples to be applied in their daily job life.
For online trainings the access link will be sent 2-3 days before the start of the training.
5% discount for registrations within 1 month before the start of the training, 10% discount for registrations within 2 months before the start of the training. VAT not included. Please inquire for discounts for multiple registrations. Discounts are not cumulative.
In order to cancel enrolment to an event, please email firstname.lastname@example.org within 2 weeks before the starting date of the event. Once this term will be expired, the entire fee will be charged.
It is possible to replace a participant attendance without additional cost, simply by contacting email@example.com. It is asked to notify the participant replacement request within 5 days before the starting date of the course/event, specifying the full name and surname of the enrolled participant as well as the full name and surname of the substitute.
If the minimum number of participants is not reached, Pharma Education Center reserves the right to cancel or schedule the event for another date. Formal communication will be given within 5 days before the event date. In this case Pharma Education Center will refund the registration fee in full and without additional charges. Alternatively, the participant can request a spendable coupon for participating in another PEC event scheduled in the current year.
Director of medical device division at NDA Group AB
Tina Amini was recently a director of medical device divison at NDA Group AB where she has been supporting MedTech and Pharma companies with their medical devices, in vitro diagnostic devices (IVD) including companion diagnostics and combination products. Tina formerly held the positions of Head of Notified Body and Senior Technical Specialist at LRQA Notified Body and Pharmaceutical & Medical Device Expert at BSI Notified Body, where she was responsible for device/drug combination products, Conformity Assessment of a wide range of medical devices and onsite assessments of Quality Management Systems (QMS) as the lead auditor. Tina was also involved in the classification of borderline products, EU pre-submission scientific advice procedures for medical devices, the consultation process with several EU competent authorities and EMA for device/drug products. She was a member of Team-NB Working Group: Borderline issues and new technologies, Classification and borderline; Post Market and Clinical. Prior to joining Notified Bodies, Tina worked in the pharmaceutical industry on the development of medicinal products and combination products in several therapeutic areas.
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